A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

10,777

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

March 31, 2009

Study Completion Date

November 30, 2009

Conditions
Obesity
Interventions
DRUG

Sibutramine hydrochloride

One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)

DRUG

Placebo

1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)

DRUG

Sibutramine hydrochloride

10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management

Trial Locations (1)

60064

Global Medical Services, North Chicago

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY